Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

Periampullary Carcinoma Nos Clinical Trial

Official title:

Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468779
• Other study ID #: 09256
• Secondary ID: HCPA09256
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2011
• Last updated: March 1, 2017
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in need of surgery for periampullary cancer

Exclusion Criteria:

• Patients submitted to periampullary surgery without pathologic confirmation of cancer

• Patients unwilling to be a part of the trial

Related Conditions & MeSH terms

• Carcinoma
• Periampullary Carcinoma Nos

Intervention

Dietary Supplement:
• Probiotics
The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery.
• Sugar pill

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period	participants will be followed for the duration of hospital stay, an expected average of 15 days
Secondary	Postoperative infection rate	To assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.	participants will be followed for the duration of hospital stay, an expected average of 15 days

External Links

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